FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Material, Dressing, Surgical, Polylactic Acid
PMA: P840062
·
Supplement: S054
·
Decision Jan 26, 2016
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Material, Dressing, Surgical, Polylactic Acid
- Trade Name
- COLLACOTE, COLLATAPE, COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY
- PMA Number
- P840062
- Supplement Number
- S054
- Device Class
- FDA Class 3
- Product Code
- LPG
- Generic Name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Medical Specialty
- Unknown
- Advisory Committee
- Dental
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- January 26, 2016
- Date Received
- December 28, 2015
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
ADDITION OF THE KINEMATICA POLYTRON PT 2500E MIXER TO IMPROVE THE TEST METHOD OF DISPERSION SAMPLES PREPARATION TO PROVIDE HOMOGENOUS SAMPLING FOR PERCENT SOLIDS TESTING.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPG | Material, Dressing, Surgical, Polylactic Acid | FDA class 3 | Unknown |